This proposal discusses the identification, evaluation and development of two novel prostate tumor specific markers and three novel prostate tissue specific markers for the diagnosis and prognosis of human prostate cancer. Prostate cancer is the second leading cause of death among men in the U.S. Good prognosis depends on the early detection and also accurate staging of the disease. However, the sensitivity and the specificity of the currently available diagnostic/prognostic markers is not sufficient. Using improved cDNA library subtraction and PCR subtraction technologies and several mRNA characterization procedures, including RT-PCR, microarray approach, Northern blot analysis and quantitative real time PCR, we have identified two novel prostate tumor specific and three novel prostate tissue specific genes. These novel genes will be further evaluated alone and/or in combination to determine the optimal combination of genes for use in real time PCR whole blood assay for diagnosis and/or prognosis of prostate cancer. Advances have already been achieved at Corixa in identifying these novel cancer markers. This in combination with collaboration with key investigator in the area of prostate cancer and access to an extensive blood and tissue bank should enable the goals of this proposal to be achieved. PROPOSED COMMERCIAL APPLICATIONS: The proposed studies will lead to commercialization of a real time PCR assay for diagnosis and /or prognosis of prostate cancer. Such tests would be marketed both in the U.S. and worldwide. The estimated world wide market for such a tests is $200-300 million/year.